Kornimate/medical-research-clean huggingface dataset:
long-term safety study of arsenic trioxide in newly diagnosed, low-to-intermediate risk acute promyelocytic leukemia

Conditions: Acute Promyelocytic Leukemia

Summary: the therapeutic advantage of the association of atra + arsenic trioxide is more favorable and manageable as compared to atra + chemotherapy. nevertheless, at present, there is not enough information on the incidence of long-term side effects. this study, as well as other similar studies conducted around europe, will focus on following patients treated with this therapy on a long-term basis. once all studies in europe will be concluded, all data will be analyzed together.

considering the clear therapeutic advantage associated with atra+ato combination therapy and the more favorable and overall manageable safety profile compared to atra+chemotherapy, the benefits of the combination in the first-line indication do appear to overweigh the risks. however, no information regarding the actual adverse event (ae) incidence and the long-term toxicity of atra+ato is available at present and therefore, as a postmarketing commitment, teva (the company holding the marketing authorisation of trisenox® (arsenic trioxide)) is setting up a long-term safety cohort study of trisenox in newly diagnosed low- to intermediate-risk apl patients retrospectively analyzing data from apl disease registries all around europe. as a result, this observational study is part of the retrospective pass study (a post-authorisation long-term retrospective safety cohort study of arsenic trioxide in first line low-to intermediate-risk acute promyelocytic leukaemia patients) that will use data from multinational apl disease registries in europe. the present study will focus on italian patients.

Eligibility criteria:
inclusion criteria: * apl diagnosis based on cytological criteria and confirmed by the presence of the (15;17) translocation and/or the presence of the pml/rara rearrangement (with the determination of the breakpoint subtype). * newly diagnosed low- to intermediate-risk apl (white blood cells \[wbc\] count ≤10x103/µl) * first line treatment with atra+ato * aged 18 years or above * signed informed consent, if applicable exclusion criteria: * high risk apl (wbc count \> 10x103/µl) * apl relapse

Keywords: acute promyelocytic leukemia adults arsenic trioxide
stem cell transplantation for hurler

Conditions: Mucopolysaccharidosis I; Mucopolysaccharidosis VI; Mannosidosis; Mucolipidosis Type II (I-cell Disease)

Summary: the purpose of this study is to determine the safety and engraftment of donor hematopoietic cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming) cell transplant for hurler syndrome, maroteaux lamy syndrome, mannosidosis, or i-cell disease.

prior to transplantation, subjects will receive busulfan intravenously (iv) via the hickman line four times daily for 4 days, cyclophosphamide intravenously via the hickman line once a day for 4 days, and anti-thymocyte globulin iv via the hickman line twice daily for three days before the transplant. these three drugs are being given to subjects to help the new marrow "take" and grow. on the day of transplantation, the donor's hematopoietic cells will be transfused via central venous catheter. after hematopoietic cell transplant, subjects will then receive two drugs, cyclosporin and either methylprednisolone or mycophenolate mofetil (mmf). cyclosporin and methylprednisolone or mmf are given to help prevent the complication of graft-versus-host disease and to decrease the chance that the new donor cells will be rejected.

Eligibility criteria:
inclusion criteria: * patients with mucopolysaccharidosis, type i (e.g., hurler syndrome), maroteaux-lamy syndrome (mps vi), alpha mannosidosis, or mucolipidosis type ii (i-cell disease) who have an hla-identical or mismatched (at 1 antigen) related marrow, pbsc, or cord blood donor. * patients with mucopolysaccharidosis, type i, maroteaux-lamy syndrome (mps vi), alpha mannosidosis, or mucolipidosis type ii (i-cell disease) who have an hla-identical or hla-1 antigen mismatched unrelated marrow, pbsc, or hla-0-2 antigen mismatched umbilical cord blood donor. * patients with mps type i, maroteaux lamy syndrome (mps vi), or mucolipidosis type ii (i-cell disease) will have a mental developmental index within two standard deviations of the normal mean, as best as can be determined using bayley scales of infant development or other standardized testing, recognizing that these may be affected by speech and/or hearing impairment. * adequate organ function: * cardiac: ejection fraction \>40%; no decompensated congestive heart failure or uncontrolled arrhythmia * renal: serum creatinine \<2.0 mg/dl * hepatic: total bilirubin \<3x upper limits of normal transaminases \< 5.0 x upper limits of normal * signed consent. exclusion criteria: * presence of major organ dysfunction (see above) * pregnancy * evidence of hiv infection or known hiv positive serology * patients or parents are psychologically incapable of undergoing bmt with associated strict isolation or documented history of medical non-compliance * patients \>50 kg may be at risk for having cell doses below the goal of ≥ 10 x 106 cd 34 cells/kg and therefore will not be eligible to receive unrelated pbscs.

Keywords: stem cell transplant storage disease errors of metabolism
biomarker study of pancreatic neuroendocrine tumours

Conditions: Pancreatic Neuroendocrine Tumor

Summary: the biology of pancreatic neuroendocrine tumors can change during the disease course. this evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. this study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, dotatoc-pet, fdg-pet and core needle biopsy with histopathological analysis (ki67 index and tumor cell differentiation). uptake on 68ga-dotatoc and 18f-fdg-pet will be correlated directly to tumor cell proliferation rate. fraction of patients with spatial heterogeneity in dotatoc as well as fdg uptake as well as metachronous changes in all collected data will be documented. biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility criteria:
inclusion criteria: * age ≥18 years * informed consent * pathology confirmed diagnosis of pancreatic neuroendocrine tumor who grade 1-3 or neuroendocrine carcinoma grade 3. exclusion criteria: * patient does not consent * pregnancy or no contraceptive in fertile women.
video-assisted thoracic surgery (vats) versus axillary mini-thoracotomy for the treatment of recurrent spontaneous pneumothorax

Conditions: Pneumothorax

Summary: the investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution. the main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.


Eligibility criteria:
inclusion criteria: * ipsilateral recurrent spontaneous pneumothorax * first episode of contralateral pneumothorax exclusion criteria: * none

Keywords: video-assisted thoracic surgery axillary mini-thoracotomy bullectomy
pragmatic clinical trials in scleroderma

Conditions: Scleroderma, Systemic; Sclerosis, Systemic

Summary: systemic sclerosis (ssc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. ssc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (smr) in studies of prevalent cases. this mortality may be increased in the early years of the disease, reaching a smr of 4 in a multinational inception cohort. in general, treatment strategies target involved organs as early as possible to avoid damage. many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. the heterogeneous features of ssc may make trials challenging. the current guidelines available are the british guidelines (2017) , and the updated european league against rheumatism (eular) guidelines, published in 2017. management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms. with the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. using the treatments that have already been proved useful in ssc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them. patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. there will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.


Eligibility criteria:
inclusion criteria: * any patient with an age \>18 years meeting the 2013 ssc classification criteria managed at the rheumatology division, st. joseph's healthcare london. * patients who refuse to be randomized for treatments but wish to provide their data for the registry will also be included, after signing the informed consent form. exclusion criteria: * refusal to participate or to sign an informed consent form.
pain, anxiety, and comfort levels in coronary angiography

Conditions: Pain; Anxiety; Nursing Caries

Summary: the study was designed as a descriptive study. the universe of the study is i̇zzet baysal training and research hospital; it consists of patients who underwent coronary angiography in the coronary intensive care unit.

in the first part, the descriptive information of the patients will be used, and in the second part, "perianesthesia comfort scale", "state/trait anxiety scale" and "general comfort scale (gas)" adapted into turkish by üstündağ and aslan in 2010 will be used. visual pain scale will be used for pain measurement. it is planned that the data for the perianesthesia comfort scale (pci) will be collected in the patient's room on the first postoperative day, in approximately 15 minutes, by face-to-face interview method.

Eligibility criteria:
inclusion criteria: * over 18 years conscious patients exclusion criteria: * patients undergoing intubation
evaluation of the f&p caramel nasal mask, us, 2023

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this clinical investigation is to evaluate the performance and safety of the f\&p caramel nasal mask in a home environment.


Eligibility criteria:
inclusion criteria: * persons who are ≥22 years of age * persons who weigh ≥66 pounds * persons who have been prescribed pap therapy by a physician * persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial * persons who are compliant with pap therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial * persons who are fluent in spoken and written english * persons who possess the capacity to provide informed consent exclusion criteria: * persons who are intolerant to pap therapy * persons who possess, or suffer from, anatomical or physiological conditions which make pap therapy inappropriate * persons who are required to use pap therapy for \>12 hours per day or for extensive periods, not including sleep or naps * persons who are trying to get pregnant, are pregnant, or think they may be pregnant * persons who have an ipap pressure of \>30 cmh2o if on bpap * persons who use a pap therapy device for the delivery of medicines, except supplemental oxygen * persons who use a pap therapy device that does not possess data recording capabilities to capture ahi and a numerical indicator of leak that is accessible to the investigation site
haplo-cord hct vs. haplo-hct for t-all patients

Conditions: Acute T Cell Lymphoblastic Leukemia; Haploidentical Hematopoietic Stem Cell Transplantation; Cord Blood

Summary: the goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord hct) works to treat acute t cell lymphoblastic leukemia (t-all). it will also learn about the safety of the transplantation. the main questions it aims to answer are: dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-hct) lower the rate of relapse? what medical problems do participants have when having haplo-cord hct? researchers will compare haplo-cord hct to haplo-hct to see if haplo-cord hct works to treat t-all. participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.


Eligibility criteria:
inclusion criteria: * patients with acute t cell lymphoblastic leukemia * with available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction * willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor * with eastern cooperative oncology group (ecog) performance status of 0-3 * signing an informed consent form, having the ability to comply with study and follow-up procedures exclusion criteria: * with other malignancies * failing to acquire a suitable unrelated cord blood unit * with a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor t cell therapy * with uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation * with severe organ dysfunction * in pregnancy or lactation period * with any conditions not suitable for the trial (investigators' decision)
sentinel lymph node biopsy after neoadjuvant chemotherapy in initially node positive breast cancer patients, could it omit axillary dissection ?

Conditions: Sentinel Lymph Node

Summary: the aim of this study is to determine the accuracy and safety of slnb after neoadjuvant chemotherapy.

breast cancer is the most common cancer among women. the morbidity and mortality of breast cancer are much higher than those observed with other female cancers . the incidence of breast cancer increases with age. approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage neoadjuvant chemotherapy (nact) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease. . encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors. neoadjuvant chemotherapy (nact) could reduce surgical morbidity of the breast and axilla. by down staging of the tumor, nact can convert patients who are candidates for mastectomy to breast-conserving surgery (bcs) candidates . furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for bcs. another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided . in the treatment of breast cancer, sentinel lymph node biopsy (slnb) has replaced axillary lymph node dissection (alnd) as the staging procedure for patients with clinically node-negative disease. it provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than alnd. historically, patients who were clinically node-negative would undergo slnb, whereas patients who were node-positive underwent alnd. slnb in the neoadjuvant setting has become a topic of debate. unfortunately, the reliability of slnb after nac remains questionable. chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.

Eligibility criteria:
inclusion criteria: 1. female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either fna or core biopsy 2. female patient aged from 18 to 60 years old 3. patients who are fit for general anesthesia. 4. patient who agree to provide short term outcome data and agree to provide contact information to provide contact information. exclusion criteria: 1. stage 4 breast cancer 2. patient has no clinical response to nact 3. patients who are contraindicated for radiotherapy 4. pregnant patients in first trimester 5. patient with inflammatory carcinoma
can warm skin disinfection reduce the pain peripheral central catheter application in premature babies?

Conditions: Pain, Acute; Premature

Summary: peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. there are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. in our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. with a prospective randomized study, the investigators wanted to document their observational data scientifically.

babies under 32 gestation week and 1250 g who are treated at level 3 nicu and need peripheral central catheter will be included in the study. in the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. the investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. the investigators predicted that the premature baby would have less discomfort with warm povidion iodine. to demonstrate this, it was planned to take both video recordings during the application and n-pass evaluation by an experienced person who does not know the povidone iodine temperature used .in preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. the catheters were administered by a single experienced person. the study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the n-pass assessment.

Eligibility criteria:
inclusion criteria: below 32 gestational weeks and / or 1250 grams preterm babies neonates requiring total parenteral nutrition, antibiotic therapy for at least 7 days, - exclusion criteria: major congenital anomalilies refusal to sign consent patient with previously attemped or placed central lines -

Keywords: premature, pain score, picc line
effectiveness of physiotherapy for chronic shoulder pain

Conditions: Shoulder Pain

Summary: the purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain. the main study hypotheses are that (i) a 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.

chronic rotator cuff pathology (crcp) is a common cause of musculoskeletal morbidity in the community. physiotherapy is often the first line of management for this condition. however, the effectiveness of physiotherapy for crcp has not been well studied. thus this project primarily aims to investigate the effect of a multimodality physiotherapy program to treat crcp where effect is measured in terms of pain, disability and health-related quality of life. the secondary aim is to evaluate the cost-effectiveness of physiotherapy as a treatment for crcp. comparison: physiotherapy program comprising stretches, exercises, manual techniques versus placebo physiotherapy

Eligibility criteria:
inclusion criteria: * diagnosis of crcp as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test; * symptoms of pain in shoulder for \> 3 months; * average movement pain \> 3 on a 10 cm visual analogue scale; * aged ≥ 18 years; * able to understand written and spoken english. exclusion criteria: * severe pain at rest, defined as \> 7 on a visual analogue scale; * global restriction of shoulder movements; * systemic inflammatory joint disease; * x-ray evidence of shoulder osteoarthritis or fracture; * calcification about the shoulder joint; * reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound); * previous shoulder surgery on affected arm; * physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months; * commenced non-steroidal antiinflammatory medication (nsaids) or conservative intervention in past 2 weeks.

Keywords: physiotherapy exercise manual therapy shoulder pain rotator cuff
effects of internal limiting membrane peeling on visual function in epiretinal membrane surgery

Conditions: Retinal Disease; Epiretinal Membrane

Summary: the patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. after removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ilm) peeled off with the epiretinal membrane. (group 1: spontaneous ilm peeling) if it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (group 2: active ilm peeling, group 3: no ilm peeling) the outcomes of the three groups will be compared.


Eligibility criteria:
inclusion criteria: * age equal to or older than 19 years * patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery exclusion criteria: * accompanied with retinal vascular disease or intraocular inflammation * prior treatment with vitrectomy in the study eye * history of glaucoma

Keywords: internal limiting membrane peeling